Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA for active immunisation to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years.
This is the first breakthrough therapy designation for a MenB vaccine to help protect children as young as 1 year of age. Trumenba previously received breakthrough therapy designation in 2014 for the prevention of MenB in adolescents and young adults ages 10 through 25 years, and later the same year received FDA approval as the first MenB vaccine approved in the U.S.
As noted in the October 2014 approval letter, Pfizer was required to assess the safety and effectiveness of Trumenba in children down to 1 year of age. Pfizer has successfully completed Phase 2 studies in this investigational age group and these data have been submitted to the FDA. These data supported Pfizer’s request for breakthrough therapy designation.
